Evidence map›Paper›PMID 37970718›Full record

Trial reportArteriosclerosis, thrombosis, and vascular biology2024

Factor XI Inhibition for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Undergoing Central Line Placement: A Phase 2 Clinical Trial.

Michael A Pfeffer, Tia C L Kohs, Helen H Vu, Kelley R Jordan, Jenny Si Han Wang, Christina U Lorentz, Erik I Tucker, Cristina Puy, Sven R Olson, Thomas G DeLoughery and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Arteriosclerosis, thrombosis, and vascular biology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04465760 (A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
10.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04465760 phase2terminatednot on this map

A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis

TypeinterventionalSponsorOHSU Knight Cancer InstituteRan2021 to 2021Enrolled9ConditionsLymphoma, Malignant Solid Neoplasm, Plasma Cell MyelomaArmsXisomab 3G3
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 37 citations in OpenAlex.

  1. Review
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  6. Risk Factors for Catheter-Related Thrombosis.Journal of clinical medicine · 2026
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  15. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 1 country.

Michael A PfefferDivision of Hematology and Medical Oncology (M.A.P., S.R.O., T.G.D., J.J.S.), Oregon Health & Science University, Portland.
Tia C L KohsDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.
Helen H VuDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.
Kelley R JordanDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.
Jenny Si Han WangDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.ORCID 0000-0002-1709-5339
Christina U LorentzDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.ORCID 0000-0002-6885-2352
Erik I TuckerDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.
Cristina PuyDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.
Sven R OlsonDivision of Hematology and Medical Oncology (M.A.P., S.R.O., T.G.D., J.J.S.), Oregon Health & Science University, Portland.ORCID 0000-0002-2717-4620
Thomas G DeLougheryDivision of Hematology and Medical Oncology (M.A.P., S.R.O., T.G.D., J.J.S.), Oregon Health & Science University, Portland.
Monica T HindsDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.ORCID 0000-0002-5267-3376
Ravi S KeshariCardiovascular Biology Research Program, Oklahoma Medical Research Foundation (R.S.K., F.L.).
David GailaniDepartment of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN (D.G.).ORCID 0000-0001-8142-8014
Florea LupuCardiovascular Biology Research Program, Oklahoma Medical Research Foundation (R.S.K., F.L.).
Owen J T McCartyDepartment of Biomedical Engineering (T.C.L.K., H.H.V., K.R.J., J.S.H.W., C.U.L., E.I.T., C.P., M.T.H., O.J.T.M., J.J.S.), Oregon Health & Science University, Portland.
Joseph J ShatzelDivision of Hematology and Medical Oncology (M.A.P., S.R.O., T.G.D., J.J.S.), Oregon Health & Science University, Portland.
Oregon Health & Science University · USOklahoma Medical Research Foundation · USVanderbilt University Medical Center · US

Funding

Upgrade of confocal microscopy at the Oregon National Primate Research CenterP51OD011092 · OD · OREGON HEALTH & SCIENCE UNIVERSITY · PI Bonnie J. Nagel · 2012 to 2026
$203.9M
Characterization of Coagulation Factor-platelet Interactions: Role of FXIR01HL101972 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI Owen J McCarty · 2010 to 2026
$8.5M
Biochemistry and Pathophysiology of Factor XI and Contact ActivationR35HL140025 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI GAILANI, DAVID · 2018 to 2024
$5.5M
Factor XI inhibitor for thrombosisR44HL106919 · NHLBI · ARONORA, INC. · PI LORENTZ, CHRISTINA U, TUCKER, ERIK IAN · 2012 to 2019
$5.0M
Evaluating the Safety and Efficacy of Targeting the Contact Pathway to Prevent Device Associated Thrombosis.R01HL151367 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI SHATZEL, JOSEPH JAMES · 2020 to 2024
$1.5M
NHLBI NIH HHS R01 HL101972NHLBI NIH HHS R01 HL151367NHLBI NIH HHS R35 HL140025NHLBI NIH HHS R44 HL106919NIH HHS P51 OD011092
6 · The paper itself

Abstract

backgroundDespite the ubiquitous utilization of central venous catheters in clinical practice, their use commonly provokes thromboembolism. No prophylactic strategy has shown sufficient efficacy to justify routine use. Coagulation factors FXI (factor XI) and FXII (factor XII) represent novel targets for device-associated thrombosis, which may mitigate bleeding risk. Our objective was to evaluate the safety and efficacy of an anti-FXI mAb (monoclonal antibody), gruticibart (AB023), in a prospective, single-arm study of patients with cancer receiving central line placement.

methodsWe enrolled ambulatory cancer patients undergoing central line placement to receive a single dose of gruticibart (2 mg/kg) administered through the venous catheter within 24 hours of placement and a follow-up surveillance ultrasound at day 14 for evaluation of catheter thrombosis. A parallel, noninterventional study was used as a comparator.

resultsIn total, 22 subjects (n=11 per study) were enrolled. The overall incidence of catheter-associated thrombosis was 12.5% in the interventional study and 40.0% in the control study. The anti-FXI mAb, gruticibart, significantly prolonged the activated partial thromboplastin time in all subjects on day 14 compared with baseline (

conclusionsFXI inhibition with gruticibart was well tolerated without any significant adverse or bleeding-related events and resulted in a lower incidence of catheter-associated thrombosis on surveillance ultrasound compared with the published literature and our internal control study. These findings suggest that targeting FXI could represent a safe intervention to prevent catheter thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04465760.

Indexed as

NeoplasmsThrombosisCathetersFactor XIHemorrhageHumansProspective StudiesFactor XIfactor XIfollow-up studiesneoplasmsthromboembolismthrombosis

Identifiers

PMID37970718
PMCPMC10877270
OpenAlexW4388731368

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.